Olaratumab plus Gemcitabine and Docetaxel in Soft Tissue Sarcoma -JGDL
Research type
Research Study
Full title
A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma
IRAS ID
198559
Contact name
Robin Jones
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2015-001316-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
Summary of Research
Soft tissue sarcomas (STS) are cancers that develop from cells in the soft, supporting tissues of the body including muscle, fat, and fibrous tissue. STS are rare, comprising approximately 1% of adult cancers. When the disease is localised, it is usually treated using surgery with or without radiotherapy and/or chemotherapy. Unfortunately, STS recurs frequently as metastatic disease, at which time doxorubicin chemotherapy is considered the standard treatment option for most patients.Olaratumab (study medication) is a human antibody that binds to platelet-derived growth factor receptors, blocking the pathways which may result in tumour cell growth and spread of the cancer. In a recent clinical trial, Olaratumab in combination with Doxorubicin chemotherapy demonstrated a significant improvement in overall survival over doxorubicin alone in patients with advanced soft tissue sarcoma. However Doxorubicin-based chemotherapy may not be suitable for some patients therefore this study (I5B-MC-JGDL) plans to explore Olaratumab in combination with other chemotherapy drugs: Gemcitabine and Docetaxel.
The first part (Phase 1b) of the study will consist of a dose-escalation assessment of the safety and tolerability of Olaratumab with Gemcitabine and Docetaxel. This part will include 30 patients in the USA, France and Spain. After the most appropriate dose of Olaratumab in combination with Gemcitabine and Docetaxel has been confirmed, the Phase 2, randomised, placebo-controlled part of the study will open to enrolment. Approximately 166 patients in the USA,France, Germany, Hungry, Israel, Italy, Poland, Spain and UK will be randomised in a 1:1 ratio to Arm A (Olaratumab plus Gemcitabine and Docetaxel) or Arm B (placebo plus Gemcitabine and Docetaxel). To be eligible to participate in this study, patients must have advanced or metastatic STS which cannot be cured by surgery and/or radiotherapy. Study assessments will include: physical examinations, questionnaire completion, blood tests, biopsies, ECG and radiological scans (CT, MRI.)
Summary of Results
Eli Lilly will not be providing a lay summary at this time.REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/1701
Date of REC Opinion
4 Nov 2016
REC opinion
Further Information Favourable Opinion